Medical Devices Under FDA Scanner

The standoff between the food and drug administration (FDA) and the medical fraternity over drugeluting stents is but one example of poor regulation of the medical devices sector in India, say healthcare experts.

A preliminary survey undertaken by the FDA bears this out, said administration officials. "We found intraocular lenses are given to stockists at Rs 2,000. These stockists or wholesalers then keep their consignments at hospitals. By the time, a lens reaches the patient, he or she has to shell out almost Rs 7,000 for it," said an FDA official.

TOI reported on Thursday that the FDA had thrown the rule-book at hospitals stocking cardiac medicated stents without proper paperwork. "Hospitals have been storing stents without purchase paper or a licence. This is not allowed because stents have been classified in India as drugs," the official said. As a result of the FDA drive, many stockists have withdrawn their consignments"which were kept for free until patients paid for them"from various big hospitals.

On Thursday, however, FDA officials told TOI that it was conducting a survey of the medical device-drug sector. "There are 10 medical devices, including orthopaedic joints, heart valves and stents, which are classified as drugs due to their composition and use. Each of these is stored, distributed and sold without adhering to norms," an official said.

The FDA survey has come up with shocking findings. "There is a multinational company that manufactures stents and sells them to stockists\wholesalers at Rs 45,000. But in most big hospitals, patients pay between Rs 90,000 and Rs 1.05 lakh for the same device," the official said. He indicated that agents, stockists and hospitals all put a premium on the price.

Take the case of heart valves. "We found a manufacturer whose cost price for stockists for a type of heart valve was Rs 40,000, but patients had given Rs 68,000 for the same," the official said.

A senior cardiologist said that the goings-on indicate the need for guidelines to regulate the sector. "It’s time the government laid down clearly what needs to be done and what will not be tolerated," he said.

FDA joint commissioner (vigilance) Dilip Shrirao confirmed that the FDA was carrying out a survey. "We cannot divulge the details. The FDA is still studying the various lifesaving drugs and devices and we will send our findings to the government of India for appropriate decision," he said.

Meanwhile, stockists continued to pull out their consignments from hospitals. A wholesaler said that a five-star hospital from the western suburbs had asked him to either take back his consignment. "The authorities there said they could only keep some of the stents."

Doctors said there was no dearth of stents for procedures during the day. "However, if during an angiography we find that the patient needs stents immediately, we are unable to procure them. We then ask the patient to come back," said a doctor. FDA officials said they would find an amicable solution soon.

Sensing Medical Malpractice

Certain heart patients with blockages in arteries need medicated stents, called drug-eluting stents, to ensure that the arteries don’t get clogged again

Medicated stents cost patients over Rs 90,000 a piece. But the food and drug administration (FDA) found that retail units in city hospitals store stents of varying diameter, length and medication without any paperwork. They found that the retail units are usually located next to the catheterization laboratory and orders are placed at a moment’s notice

An FDA official said that price control does not come under the administration’s jurisdiction, but there is a gross discrepancy between the cost price of stents and the price at which they are sold to patients. He said the area needs greater regulation

The FDA is also studying the practice of huge discounts to hospitals that place bulk orders for stents every month. But the discount is rarely passed on to patients, the official said

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